Feasibility of Telehealth Palliative Care and Digital Symptom Monitoring for Patients With Acute Myeloid Leukemia
The Feasibility of Telehealth-Based Palliative Care Intervention and Digital Symptom Monitoring on Patients With AML Receiving Low-Intensity Induction Therapy
AML is the most common leukemia diagnosed in adults. In spite of recent low-intensity therapies that have improved outcomes for older AML patients, AML remains associated with poor prognosis as well as high symptom burden. While the benefits of early palliative care as well as electronic PROs have been well-described in the oncology population, neither have been well-studied in the AML population, and have never been studied in combination. We propose a prospective, single-center, single-arm trial to evaluate the feasibility of a virtually-mediated supportive care model utilizing both electronic PROs and palliative care for patients with AML being treated with low-intensity therapy.
AIM1: is to evaluate and describe the feasibility of implementing early specialty palliative care referrals carried out via telehealth/video-based modalities in combination with digital symptom monitoring for patients recently diagnosed with acute myeloid leukemia (AML) and starting low intensity induction therapy.
AIM2: study the differences in health-related quality-of-life (HRQoL) metrics using patient-reported outcomes (PROs) in patients recently diagnosed with AML and starting low intensity induction therapy who receive early referral to telehealth/video-based palliative care visits compared to standard care.
AIM3: to explore the patient experience of patients with AML on low-intensity therapy, capture rates of advance care planning, hospice utilization, and hospital utilization.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
California
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Palo Alto, California, United States, 94304
- Stanford University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients being treated for a diagnosis of acute myeloid leukemia at Stanford Cancer Center
- Patients determined to be candidates for low intensity induction therapy (not requiring hospitalization to administer treatment) by their leukemia physician
- Estimated life expectancy of 6 months
- Functional status at the level of at least being capable of limited self-care, confined to chair or bed for half the day or better
- Access to smartphone, tablet, or computer with capability to utilize a symptom tracking application
Exclusion Criteria:
- Relapsed or refractory AML
- Patients who have established care with palliative care previously
- Non-English-speaking, as the Noona application is developed in the English language
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: All patients
All patients enrolled in this trial will be referred to palliative care for planned monthly virtual visits, be instructed on the use of a digital application Noona that can be downloaded on their personal electronic device, and will be prompted to fill out symptom questionnaires using Noona prior to palliative care visits (required) as well as weekly (optional).
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Previously described in Arm description
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of completed palliative care referrals and monthly visits
Time Frame: Through study completion, an average of 6 months
|
This will be measured as a percentage of patients who overall complete the initial palliative care referral and at least 50% of their scheduled monthly visits
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Through study completion, an average of 6 months
|
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Rate of usage of digital symptom monitoring application, Noona
Time Frame: Through study completion, an average of 6 months
|
This will be measured by the percentage of patients who complete at least 50% of Noona surveys associated with their palliative care visits
|
Through study completion, an average of 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean change in Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) scores
Time Frame: Baseline, 3 months, and 6 months
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Health-related quality of life instrument used in patients with acute myeloid leukemia, minimum score 0, maximum score 176, higher scores indicating worse quality of life
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Baseline, 3 months, and 6 months
|
|
Mean change in Hospital Anxiety and Depression Scale (HADS) scores
Time Frame: Baseline, 3 months, and 6 months
|
Hospital Anxiety and Depression survey used to measure anxiety and depression, minimum score 0, maximum score 42, with higher scores indicating increased anxiety/depression
|
Baseline, 3 months, and 6 months
|
|
Mean change in Patient Health Questionnaire (PHQ)-9 scores
Time Frame: Baseline, 3 months, and 6 months
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Minimum score 0, maximum score 27, with higher scores indicating worse mood
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Baseline, 3 months, and 6 months
|
|
Mean change in Satisfaction with Decision-Making Scale scores
Time Frame: Baseline, 3 months, and 6 months
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Minimum score 6, maximum score 25, with higher scores indicating improved satisfaction
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Baseline, 3 months, and 6 months
|
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Overall satisfaction with usage of Noona questionnaire
Time Frame: Baseline, 6 months
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Measured qualitatively, by whether patients strongly agree, somewhat agree, are neutral, somewhat disagree, or strongly disagree with statements regarding the Noona instrument
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Baseline, 6 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kavitha Ramchandran, MD, Stanford University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-60285
- NCI-2022-03013 (Registry Identifier: CTRP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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